Masticatory soft elastic gelatin capsules and method for the manufacture thereof

ABSTRACT

A chewable, filled, one-piece soft elastic gelatin (SEG) capsule. The capsule includes a shell which is formed from a formulation of gelatin, water, a plasticizer, and a masticatory substance. The masticatory substance is present in the shell in an amount of about 1-75 percent by weight and the gelatin is present in the shell in an amount of about 10-90 percent by weight. A fill material is contained within the shell. The fill may be selected from a variety of materials, including candy, various confectionaries, antacids, cough and cold preparations, sore throat remedies, antiseptics, dental preparations, such as fluorides, breath fresheners, and the like. In manufacturing the SEG capsules, a molten gel mass is prepared with a dispersion of a molten masticatory substance therein. A suitable fill material is also prepared. The gelatin formulation containing the masticatory substance dispersed therein is formed as a shell around the fill material. The capsules are dried until the desired chewing characteristics are attained.

REFERENCE TO RELATED APPLICATION

This is a continuation-in-part application of our co-pending U.S. patentapplication Ser. No. 262,406 filed May 11, 1981, now abandoned.

BACKGROUND OF THE INVENTION Field of the Invention and Description ofthe Prior Art

This invention relates to a unique gelatine capsule formulation and amethod for its manufacture and it particularly relates to a soft elasticgelatin capsule (SEG) formulation, usually containing a fill material,wherein the formulation may be chewed in the mouth over an extendedperiod of time.

Filled, one-piece, SEG capsules have been widely known and used for manyyears for a variety of purposes. These SEG capsules have propertieswhich are quite different from two-piece telescoping hard shellcapsules. The SEG capsules usually have a fill material, which isnormally a liquid. The fill may be any of a variety of materials, suchas industrial or cosmetic, non-consumable products, such as bath oilsand adhesives. More commonly, SEG capsules are used to encapsulateconsumable materials such as vitamins and pharmaceuticals. Withreference to the application of William R. Ebert, et al., dated Oct. 24,1980, Ser. No. 200,475, (now abandoned) there is disclosed a method andcapsule, having no added masticatory substance, wherein thecharacteristic and sometimes unpleasant flavor of gelatin is masked withmaltol or ethyl malthol. The avoidance of an unpleasant taste isparticularly important when the capsule shell is chewed or otherwisebroken in the oral cavity in order to release the fill. This is thecase, for example, with a chewable cough, cold, antacid, analgesic, orcandy type of product.

With respect to providing a chewable, SEG capsule product, there isgenerally a significant problem because the SEG capsule generallydissolves rapidly in the mouth, thereby leaving little or no residue forfurther chewing. A chewable SEG capsule product should not only benon-toxic, but it should also be of a suitable size and leave achewable, insoluble residue in the mouth and this residue should notchange significantly in size upon continued chewing; at all times, theinsoluble residue should retain a generally normal chewing texture orconsistency. In addition, it has generally been considered a problem toprepare a SEG capsule containing an insoluble masticatory substancebecause the masticatory substance and the gelatine shell formulationitself are not considered to be compatible when using conventionalformulations and SEG capsule manufacturing techniques.

SUMMARY OF THE INVENTION

It is therefore an important object of the present invention to providea chewable, filled, one-piece, SEG capsule and a process for itsmanufacture wherein an insoluble masticatory substance is containedwithin the shell.

It is another object of the present invention to provide a SEG capsulecontaining a masticatory substance wherein upon chewing of the capsulein the mouth, the size of the chewable residue does not changesignificantly and the insoluble residue retains a normal chewingconsistency over an extended period of time.

It is also an object of the present invention to provide a unique methodfor manufacturing a chewable SEG capsule wherein the method involvesdispersing a molten masticatory substance within a molten gel mass.

It is a further object of the present invention to provide an improvedchewable SEG capsule containing a fill wherein the process ischaracterized by its compatibility with known SEG capsule manufacturingtechniques, such as the rotary die process.

Further purposes and objects of the present invention will appear as thespecification proceeds.

The foregoing objects are accomplished by providing a chewable, filled,one-piece SEG capsule wherein a molten gel shell formulation is formedfrom gelatin, water, a plasticizer, and a synthetic or naturalmasticatory substance. The masticatory substance, while in a moltenstate, is dispersed within the gel formulation, also while in the moltenstate. The dispersion is thoroughly mixed. Gelatin is present in theformulation in an amount of about 10-90 percent by weight and themasticatory substance is present in the shell in an amount of about 1-75percent by weight. A fill material is formed and encapsulated within theshell. After encapsulation, the shell is dried until the SEG capsuleacquires the desired chewing texture and characteristics.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Generally speaking, the present invention relates to an improved,chewable, filled, one-piece, seamless SEG capsule. The improvement isspecifically directed to the formulation and manufacturing techniquewhich results in compatibility between an insoluble masticatorysubstance and gelatin normally used in the SEG capsule shell. Generallyspeaking, the insoluble masticatory substance is present in the gelatinshell in an amount of about 1-75% by weight while the gelatin is presenttherein in an amount of about 10-90% by weight. The present invention isspecifically directed to a SEG capsule containing a fill, usually aliquid fill, wherein the gel is heat sealable and therefore capable ofbeing manufactured on conventional rotary die encapsulation equipment.

In making the gel preparation for the shell, a molten gel mass is alsoprepared and a molten masticatory substance is dispersed in the gelmass. A fill material is prepared and the shell comprising the gel mass,with the masticatory substance dispersed therein, is formed as a shellaround the fill material. Finally, the shell is dried until the desiredchewable texture is obtained for the gel shell containing themasticatory substance.

In a preferred form of our capsule, the gelatin capsule, made inaccordance with the invention, comprises about 1-75% by weight of aknown insoluble masticatory substance, about 10-90% by weight gelatin,about 1-30% by weight of a plasticizer, such as glycerine or sorbitol,about 5-40% by weight of water, and about 0-10% taste modifiers or otheradditives. In addition, the gelatin shell will commonly contain apreservative, such as mixed parabens, ordinarily methyl or propylparabens in about a 4:1 weight ratio. The parabens are incorporated inthe shell formulation in minor proportions as compared to the totalweight of the shell formulation. Conventional SEG capsules utilizinggelatin have a bloom value of about 150-200, although this value may bevaried.

Suitable insoluble masticatory substances utilized in our invention maybe found upon reference to Federal Regulations, Title 21, Section172.615 which lists various natural and synthetic masticatory substanceswhich may be used alone or in a variety of combinations. The naturalmasticatory substances (coagulated or concentrated lattices) ofvegetable origin are as follows: Chicle, Chiquibul, Crown gum, Guttahang kang, Massaranduba balata (and the solvent-free resin extract ofMassaranduba balata), Massaranduba chocolate, Nispero, Rosidinha(rosadinha), Venezuelan chicle, Jelutong, Leche caspi (sorva), Pendare,Perillo, Leche de vaca, Niger gutta, Tunu (tuno), Chite, and Naturalrubber (smoked sheet and latex Hevea brasiliensis solids).

Suitable synthetic masticatory substances include: Butadiene-styrenerubber, isobutylene-isoprene copolymer (butyl rubber), paraffin,petroleum wax, petroleum wax synthetic, polyethylene (mol. wt.2,000-21,000), polyisobutylene (mol. wt. 37,000), polyvinyl acetate(mol. wt. 2,000), and polyvinyl alcohol (not listed in Fed. Reg.)

In the manufacturing of the chewable SEG capsules, in order to attainthe desired characteristics, that is, the desired chewingcharacteristics, it is important that the molten masticatory substanceis dispersed in the molten gel mass. Generally speaking, this dispersionof the masticatory substance in the molten gel mass is accomplished inany of a variety of ways. First, all of the ingredients, including themasticatory substance and the gel mass, are mixed together and all theingredients are heated until melted. The masticatory substance is thendispersed by thorough mixing, generally in a vacuum atmosphere, by useof a suitable mixer commonly used for preparing a molten gelatin massfor a SEG capsule shell.

In a second method, a molten gel mass is prepared by mixing theingredients (including, for example, gelatin, glycerine, and water) andmixing until the molten gel mass is formed. Suitable vehicles for thegel mass are glycerin, sorbital, water, glucose, fructose, acacia, andmannitol. Thereafter, the masticatory substance is added to the moltengel mass and the entire mixture is then heated to above the meltingpoint of the masticatory substance, which is dependent upon theparticular masticatory substance or substances that are used. Themasticatory substance is then dispersed in the molten gel mass bymixing.

Another method of preparing the dispersion of a molten masticatorysubstance in the molten gel mass is to prepare the molten gel mass, asdescribed above, add a molten masticatory substance which has beenpreviously melted, and finally, dispersing the molten masticatorysubstance in the molten gel mass through thorough mixing. An importantaspect of the method is appropriate mixing in order to prepare thedispersion of the molten masticatory substance in the molten gel mass,which result is accomplished in a variety of ways. In each of the abovemethods, any suitable flavorings or taste modifiers are added to thedispersion.

By following the above method for making the masticatory gel mass, withthe above relative proportions between the materials making up the thegel-masticatory substance mass, a desired gel, having unique propertiesincluding thermal plasticity, gel forming ability, heat sealability,reduced hydrophilic properties, ease of drying, and desired chewingcharacteristics, results.

A suitable fill material is prepared separately. Suitable fill materialsinclude candy, confectionaries, antacids, cough preparations, coldpreparations, sore throat remedies, antiseptics, dental preparationsincluding fluorides, breath fresheners and the like. The preparation ofthe fill material may be accomplished in a wide variety of ways. Thefluid material must be compatible with the gel shell and must not breakdown the shell during a period of normal storage. This problem is wellknown and is solved in a variety of ways known to those skilled in theart. Suitable vehicles for the fill are neutral oil, mineral oil, water,ethyl alcohol, vegetable oil, and fructose syrup. As with the gel mass,a suitable flavoring or taste modifier is preferably added to the fill.

Suitable taste modifiers or flavorings are used in the fill composition,the gelatin composition, or in both simultaneously. The particular tastemodifier and/or flavor that is used may vary widely. Similarly, theproportions between various taste modifiers and/or flavors vary widelyaccording to the taste desired. The taste modifiers and/or flavoringsmay be desirably selected from the following: cherry syrup, citric acid,dextrose, essential oil (i.e., clove, lemon, orange, peppermint,spearmint), ethyl vanillin, glucose, honey, mannitol, methyl salicylate,raspberry syrup, saccharin, saccharin sodium, sorbital, sucrose, wildcheryy syrup, and mixtures thereof.

The present capsules are simultaneously formed and filled with a fillmaterial, using conventional methods and apparatus, such as those usingrotary die process, as disclosed, for example, in U.S. Pat. Nos.1,970,396; 2,288,327; and 2,318,718. Such equipment is commerciallyused, for example, by R. P. Scherer Corporation and utilizes the saidrotary die process for encapsulating various fill materials in a gelmass.

The SEG chewable gelatin capsules are formed into any desired shape,color and size which is to be of such size as to be readily received andchewed in the mouth. Finally, the formed and filled capsules are driedfor a suitable length of time in order that the desired chewingcharacteristics may be attained. The particular length of time for thedrying to occur may vary over a wide range.

The following examples set forth useful SEG capsule shell formulationsand various fill materials embodying the present invention:

EXAMPLE I

    ______________________________________                                         Composition of Gel Mass in % by weight                                       ______________________________________                                        Synthetic masticatory substances                                                                         29                                                 Gelatin, Type HB           27                                                 Glycerine                  15                                                 Water                      24                                                 Taste modifiers and others 5                                                  (Mixture of powdered sugar,                                                   saccharin, mono-sodium glutamate,                                             sodium chloride, furaneol,                                                    and peppermint oil)                                                           ______________________________________                                    

Mix gelatin, glycerin and water into a fluff and heat until molten. Addthe synthetic masticatory substances and heat until molten (abovemelting point). (In this formulation, the synthetic mastic used is soldunder the trademarks PALOSA or DREYCO and is available from DreyfusCompany of South Plainfield, N.J.) Disperse the molten gum in the gelwith a suitable mixer. Add taste modifiers and other additives and mixwell. Keep gel mass at a constant temperature of 60° C. until ready foruse in encapsulation.

    ______________________________________                                         Composition of Fill Material in mg/capsule                                   ______________________________________                                        Dried Aluminum hydroxide gel, USP                                                                        282                                                Magnesium hydroxide, NF    85                                                 Simethicone, NF            25                                                 Suspending agents          125                                                (Octaglyceryl monostearate and                                                octaglyceryl monooleate)                                                      Vehicle                    378                                                (Neutral Oil)                                                                 Taste modifiers and others 505                                                (Powdered sugar, saccharin,                                                   mono-sodium glutamate, sodium                                                 chloride, furaneol, peppermint                                                oil, and citric acid)                                                         Fill wt., mg.              1400                                               ______________________________________                                    

Mix suspending agents with vehicle and simethicone. Add dried aluminumhydroxide gel and magnesium hydroxide and mix well. Add taste modifiersand other additives and mix into a smooth suspension and deaerate themixture.

Encapsulate fill material with the gel mass as prepared above on Schererrotary machine or other similar machine using the appropriate size andshape die. Dry the freshly prepared SEG capsules to the specifiedconsistency in drying chambers.

EXAMPLE II

    ______________________________________                                        Composition of Gel Mass in % by weight                                        ______________________________________                                        Natural masticatory substances                                                                          25                                                  (Mexican Chicle)                                                              Gelatin, Type HB          24                                                  Glycerin                  11                                                  Water                     37                                                  Taste Modifiers and others                                                                              3                                                   (Peppermint oil, saccharin,                                                   mono-sodium glutamate,                                                        sodium chloride, furaneol and                                                 anethole                                                                      ______________________________________                                    

Mix gelatin, glycerin and water into a fluff. Add natural masticatorysubstances and heat until molten. Disperse molten natural gum with asuitable mixer. Add taste modifiers and other additives and mix well.Keep molten gel mass at a constant 60° C. temperature untilencapsulation.

    ______________________________________                                         Composition of Fill material in mg/capsule                                   ______________________________________                                        Dextromethorphan HBr 10% adsorbate                                                                       150                                                Benzocaine                 3                                                  Suspending agents          64                                                 (Beeswax and lecithin)                                                        Vehicle                    403                                                (Soybean oil)                                                                 Taste modifiers and others 347                                                (Powdered sugar, methanol,                                                    anethole)                                                                     Fill Wt., mg.              967                                                ______________________________________                                    

Mix suspending agents with vehicle. Add dextromethorphan HBr 10%adsorbate and benzocaine and mix well. Add taste modifiers and otheradditives and mix into a smooth suspension, and deaerate the mixture.

Encapsulate the fill material with the above prepared gel mass onScherer rotary machine or other similar machines using a die of theappropriate size and shape. Dry the freshly prepared SEG capsules to thespecified consistency in drying chambers.

EXAMPLE III

    ______________________________________                                         Composition of Gel Mass in % by weight                                       ______________________________________                                        Chicle                    28                                                  Gelatin, Type HB          28                                                  Glycerin                  11                                                  Water                     28                                                  Taste modifiers and others                                                                              5                                                   (Furaneol, orange flavor,                                                     saccharine, mono-sodium                                                       glutamate, sodium chloride,                                                   citric acid)                                                                  ______________________________________                                    

Prepare gel fluff by mixing gelatin, glycerin and water. Melt gel fluffand chicle separately. Add molten chicle to molten gel mass and dispersethoroughly with a suitable mixer. Add taste modifiers and otheradditives and mix well. Keep molten gel at a constant 60° C. temperatureuntil encapsulation.

    ______________________________________                                         Composition of Fill Material in mg/capsule                                   ______________________________________                                        Brand of fructose corn syrup                                                                          3088                                                  Flavors (Orange flavoring)                                                                            2                                                     Fill wt., mg.           3090                                                  ______________________________________                                    

Add flavors to brand of fructose corn syrup and mix well. Deaerate anytrapped air before encapsulation.

Encapsulate fill material with the above prepared gel mass on Schererrotary machines or other similar machine using a die of the appropriatesize and a round shape. Dry the freshly prepared SEG capsules to thespecified consistency in drying chambers.

EXAMPLE IV Chewable Sore Throat Capsules

    ______________________________________                                         Composition of Gel Mass in % by weight                                       ______________________________________                                        Chicle                     14                                                 Synthetic masticatory substances                                                                         15                                                 (Dreyco)                                                                      Gelatin, Type HB           27                                                 Glycerin                   15                                                 Water                      24                                                 Taste modifiers and other* 5                                                  (Saccharin, methyl salicylate)                                                ______________________________________                                         *Each capsule shell to contain 8 mg. benzocaine                          

Prepare gel fluff by mixing gelatin, glycerin and water. Add bothmasticatory substances and heat until molten. Disperse molten gumsthoroughly with suitable mixer. Add taste modifiers and other additivesand mix well. Keep the molten gel mass at a constant 60° C. temperatureuntil encapsulation.

    ______________________________________                                         Composition of Fill Material in mg/capsule                                   ______________________________________                                        Acetaminophen, USP        650                                                 Suspending Agents         206                                                 (Beeswax and lecithin mixture)                                                Vehicle                   808                                                 Taste modifiers and others                                                                              1044                                                (Powdered sugar and saccharin)                                                Flavors                   137                                                 (Menthol, methyl salicylate,                                                  oil of wintergreen)                                                           Fill wt., mg.             2845                                                ______________________________________                                    

Mix the suspending agents with the vehicle. Add acetaminophen and mixwell. Add taste modifiers and flavors and mix well. Mill mix ifnecessary. Deaerate before encapsulation.

Encapsule the fill material with the above prepared gel mass on aScherer rotary machines or other similar machine using a die of theappropriate size and shape. Dry the freshly prepared SEG capsules to thespecified consistency in drying chambers.

EXAMPLE V Breath Freshener Capsules

    ______________________________________                                         Composition of Gel Mass                                                      ______________________________________                                        Gelatin               28.326% w/w                                             Water                 25.234% w/w                                             Glycerin              15.758% w/w                                             Saccharin             0.001% w/w                                              Methyl salicylate     0.002% w/w                                              DREYCO base gum       30.420% w/w                                             ______________________________________                                    

Prepare gel by mixing gelatin, glycerin and water. Add the gum and heatuntil molten. Disperse gum throughout with mixing. Add saccharin andmethyl salicylate and mix. Maintain gel mass at 60° C. untilencapsulation.

    ______________________________________                                         Composition of Fill                                                          ______________________________________                                        Neutral Oil          93.144% w/w                                              Menthol U.S.P.       2.257% w/w                                               Methyl salicylate    4.513% w/w                                               Saccharin            0.001% w/w                                               ______________________________________                                    

Mix ingredients and deaerate before encapsulation.

Encapsulate the fill in the gel mass on a Scherer rotary die machineusing a die of appropriate size and shape. Dry the capsules in a dryingchamber.

While in the foregoing there has been provided detailed descriptions ofpreferred enbodiments of the present invention, it is to be understoodthat all equivalents obvious to those having skill in the art are to beincluded within the scope of the invention as claimed.

What we claim and desire to secure by Letters Patent is:
 1. A chewable,non-toxic, filled, one piece, soft elastic gelatin capsule comprising,in combination, a shell formed from a formulation of a soluble componentof gelatin, water, and a plasticizer selected from the group consistingof glycerin and sorbital, and of an insoluble component of a masticatorysubstance, and a fill material contained within said shell, said shellformulation being capable of being formed into said shell with said fillmaterial therein, an insoluble chewable residue being formed from saidinsoluble component upon chewing of said capsule, the size of saidresidue substantially retaining its size and chewing consistency duringchewing, the relative proportions of said soluble component and saidinsoluble masticatory substance component being such that the size andchewing characteristics of said chewable residue are attained.
 2. Thecapsule of claim 1 wherein said masticatory substance is chicle.
 3. Thecapsule of claim 1 wherein said insoluble component and said solublemasticatory substance compound cooperate to form a gel mass used to formsaid shell, said gel mass comprising about 14-30% by weight of saidmasticatory substance, about 24-28% by weight of gelatin, about 11-16%by weight of glycerin and about 24-37% by weight of water.
 4. Thecapsule of claim 1 wherein said fill material comprises flavored cornsyrup.
 5. The soft elastic gelatin capsule of claim 1 wherein saidplasticizer is present in said shell formulation in an amount of about1-30 percent by weight, and said water is present in said shell in anamount of about 5-40 percent by weight.
 6. The soft elastic gelatincapsule of claim 1 wherein said masticatory substance comprises anatural masticatory substance selected from the group consisting ofChicle, Chiquibul, Crown gum, Gutta hang kang, Massaranduba balata,Massaranduba chocolate, Nispero, Rosidinha, Venezuelan chicle, Jelutong,Leche caspi, Pendare, Perillo, Leche de vaca, Niger gutta, Tunu, Chite,or Natural rubber.
 7. The soft elastic gelatin capsule of claim 1wherein said masticatory substance comprises a synthetic masticatorysubstance selected from the group consisting of Buadiene-styrene rubber,isobutylene-isoprene copolymer, paraffin, petroleum wax, petroleum waxsynthetic, polyethylene, polyisobutylene, polyvinyl acetate, orpolyvinyl alcohol.